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Starting soon Phase 3

Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults

NCT07911787 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-11-04
Last updated
2026-11-03

Condition(s) studied

SCHIZOPHRENIA 1 (Disorder)

Investigational drug(s) / intervention(s)

HS-10380 →Aripiprazole →Placebo

HS-10380: Oral;QD;W1:dose titration; W 2-3 dose adjust to optimal level;Week 4-6:stable dose

Aripiprazole: Oral;QD;W1:dose titration; W 2-3 dose adjust to optimal level;Week 4-6:stable dose

Placebo: Oral;QD;W1:dose titration; W 2-3 dose adjust to optimal level;Week 4-6:stable dose

Study summary

This is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Participant is aged 18-65 years, inclusive, at screening. * Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening. * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2. * Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\\Item 2 (P2; conceptual disorganization)\\Item 3 (P3; hallucinatory behavior)\\Item 6 (P6; suspiciousness/persecution) . Exclusion Criteria: * Judged by the investigator as having treatment-resistant schizophrenia. * Patients with risk of violent or destructive behavior, or suicidal risk. * History or presence of clinically significant neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome. * Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria. * History of severe allergic reactions. * Female patients who are pregnant, in puerperium, or lactating at screening or baseline. * History of drug abuse within 1 year prior to screening. * History of alcohol abuse within 6 months prior to screening. * Abnormal vital signs at screening or baseline. * Abnormal 12-lead ECG at screening or baseline. * Abnormal laboratory parameters at screening or baseline.

Primary outcome measure(s)

  • Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42) — Baseline and Week 6
    The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Mental Health Center Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07911787 on ClinicalTrials.gov ↗ ← All trials in China